FDA-Drug2026-10-14Class IIPROCESSING DEFECT
Carolina Infusion Tri-MIX injectable recalled for sterility assurance issue
What this means
Carolina Infusion LLC is recalling Tri-MIX (papaverine/phentolamine/alprostadil) injectable solution due to concerns that processing equipment may not have maintained proper sterility standards during manufacturing. The product is a compounded injectable medication packaged in single-use syringes for individual patient prescriptions.
- If you have received this medication, contact your healthcare provider or pharmacist immediately
- Do not use the product; return it to the pharmacy where it was dispensed
- Check your prescription records for lot 08062026@10 with a beyond-use date of 9/20/2026
The agency's original wording
Hazard
Lack of Assurance of Sterility: Related to processing equipment used in compounded product.
Intended for
Adults
Illnesses reported
None reported
Sold states
Nationwide within the U.S
Affected count
5 mL in patient specific syringe dose
Manufactured in
95 Bees Creek Rd, N/A, Ridgeland, SC, United States
Products
Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/60, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0025-2027More Carolina Infusion recalls
- FDA-Drug2026-10-14Carolina Infusion semaglutide/cyanocobalamin injectable recalled for sterility concerns
- FDA-Drug2026-10-14Carolina Infusion semaglutide injectable recalled for sterility assurance concerns
- FDA-Drug2026-10-14Carolina Infusion Sermorelin Acetate injectable recalled for sterility concerns
- FDA-Drug2026-10-14Carolina Infusion semaglutide/cyanocobalamin injectable recalled for sterility concerns
- FDA-Drug2026-10-14Carolina Infusion tirzepatide injectable recalled for sterility concerns
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